BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS LASER

    MDR report key: 2163542 · Received November 5, 2010

    Report

    Report Number
    3006695864-2010-00121
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 8, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), (FLAP SLIPPED WITH STRIAE, EPITHELIAL IN-GROWTH). EVALUATION: EQUIPMENT WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE) AFTER THE EVENT. MECHANICAL AND PERFORMANCE TEST WERE DONE INCLUDING A VISUAL EXAMINATION. FSE NOTICED IN SYSTEM ERROR-LOG A ONE TIME EVENT OF "MAIN SHUTTER ERROR" AND THEN HE PROCEEDED TO CHECK AND CLEAN THE CABLE CONNECTION OF THE MAIN SHUTTER. QUARTERLY PREVENTIVE MAINTENANCE WAS ALSO PERFORMED. NO PARTS WERE REPLACED AND LASER SYSTEM WAS FOUND TO MET AMO SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT HAD UNEVENTFUL ILASIK OU ON (B)(6) 2010. ON (B)(6) 2010, DAY 1 POST-OP, OD SLIPPED FLAP + STRIAE AND EIG (EPITHELIAL IN-GROWTH). FLAP REPOSITIONED, STRIAE AND EIG REMOVED WITH BCL PLACED ON OD. (ROUTINE POST-OP LASIK PROTOCOL EXPLAINED TO PATIENT) SURGEON TO FOLLOW UP WITH PATIENT ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER HNO AMO MANUFACTURING USA, LLC 20002

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other